The application for clinical trial of SK08 combined with immune checkpoint inhibitor in the treatment of advanced solid tumors was accepted
Release Time: 2022-01-04
On December 4, 2021, SK08 live bacteria powder, Zhiyi’s new Class 1 biotherapeutic drug, was accepted by the state drug administration (NMPA) for the clinical trial application of a new indication – immune checkpoint inhibitors (ICIs) for the treatment of advanced solid tumors (Acceptance No. CXSL2200001).
SK08 live bacteria powder is the first LBP drug developed from Bacteroides fragilis internationally, in which the clinical treatment for IBS has entered Phase II. This is also China’s first clinical application of LBPs for tumor treatment.
Animal pharmacodynamic studies show that SK08 combined with anti-PD-1 monoclonal antibodies can significantly improve the rate of immunotherapy response and inhibit tumor growth.
About ICIs Treatment of Advanced Solid Tumors:
Consisting of anti-PD-1/L1 monoclonal antibodies and anti-CTLA-4 monoclonal antibodies, ICIs has been approved to be used in the first-line and second-line treatment of patients with a variety of advanced solid tumors. It is widely used in head and neck squamous cell carcinoma, esophageal cancer, lung cancer, gastric cancer, hepatocellular carcinoma, colorectal cancer, renal cancer, urothelial carcinoma, melanoma, malignant lymphoma and other malignant tumors. The application of ICIs in some tumor patients is limited due to problems associated with drug resistance and safety in immunotherapy. Nonetheless, exploring effective combination therapy is of great significance to improve the response rate of immunotherapy.
About Us:
Guangzhou Zhiyi Biotechnology Co., Ltd. is committed to the research and development of live biotherapeutic products (LBPs), also known as next generation probiotics (NGPs). Using the fundamentals in research and industrialization, the company has established a technical platform with international standards for the research on the relationship between human pathogenic benthic bacteria and disease, target determination and screening of new functional strains, as well as the development of living biological drugs; it is a leading innovative enterprise in the industry.